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Clinical Trial Summary

This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.


Clinical Trial Description

Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:

- Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion

- Immediately before surgery

- After induction of anaesthesia and before "knife time" = start of surgery.

- At the end of surgery: Levosimendan infusion will stop.

- Approximately 4 hours after surgery immediately before extubation.

- Approximately 21 hours after surgery

- Approximately 96 hours after surgery (day 4)

- 6 months after surgery

Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.

Interim analysis will be conducted after 30 included patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01188369
Study type Interventional
Source University of Aarhus
Contact
Status Terminated
Phase Phase 4
Start date September 2010
Completion date March 2013

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